Cleared Traditional

K130736 - BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
(FDA 510(k) Clearance)

K130736 · Helix Medical, LLC · Ear, Nose, Throat device

Dec 2013

Decision

274d

Days

Class 1

Risk

K130736 is an FDA 510(k) clearance for the BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS. This device is classified as a Instrument, Ent Manual Surgical (Class I - General Controls, product code LRC).

Submitted by Helix Medical, LLC (Carpinteria, US). The FDA issued a Cleared decision on December 17, 2013, 274 days after receiving the submission on March 18, 2013.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K130736 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 18, 2013
Decision Date	December 17, 2013
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF